Kornimate/medical-research-clean huggingface dataset:
description of a retrospective cohort of patients with transthyretin cardiac amyloidosis (attr-ca) in internal medicine

Conditions: Cardiac Amyloidosis

Summary: in 2024, the prevalence of ttr cardiac amyloidosis is difficult to determine precisely. indeed, the disease has long been underdiagnosed due to a lack of effective treatment and non-invasive diagnostic methods. the prevalence of attrwt is estimated at 155 to 191 cases per million person-years, with an incidence of 36 cases per million person-years. both incidence and prevalence increase with age. the most common presentation of ttr cardiac amyloidosis is heart failure with preserved ventricular ejection fraction (lvef). the natural history of ttr cardiac amyloidosis is progression to restrictive heart disease with all the complications described above. the median time between diagnosis and the first cardiac symptoms was 39 months. currently, the median survival in france is approximately 3.5 years, but survival appears to be improving, with a mortality rate of 73.5% at 30 months between 2002 and 2006, compared to 15% at 60 months between 2017 and 2022. the number of patients diagnosed with ttr cardiac amyloidosis appears to be increasing. the overwhelming majority of available data concerns patients treated in cardiology. however, the issue of ttr cardiac amyloidosis concerns all specialists caring for patients with heart failure, particularly in internal medicine due to the high number of admissions from emergency departments, with a significant proportion of patients suffering from cardiac decompensation.


Eligibility criteria:
inclusion criteria: * sujet majeur (≥18 ans) * diagnostic d'amylose à ttr suite à une hospitalisation en médecine interne aux hus entre 01/01/2013 au 31/12/2023. exclusion criteria: * subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes. * type of amyloidosis other than attr after review of the medical record (immunological assessment, imaging assessment, expert report).

Keywords: cardiac amyloidosis internal medicine
genetic causes of familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia

Summary: familial hypercholesterolemia (fh) is a common disease. the genetic background to fh is not yet fully understood. in the present prospective cohort study we aim to study the association between different clinical characteristics, gene mutations and prognosis.

in this prospective observational cohort study of patients with high clinical suspicion of familial hypercholesterolemia (fh) we aim to study the association between different clinical characteristics, gene mutations and prognosis. the included patients will undergo physical examination and extended blood sampling. dna will be extracted and used for both whole genome sequencing and investigation of both known- , unknown- and suspected mutations associated with fh. the patients will be followed in for 15 years in the swedish patients registry and the swedish cause of death registry.

Eligibility criteria:
inclusion criteria: 1. age 8 years or older. 2. clinical suspicion of fh 3. dutch lipid clinic network score of at least four or a first grade relative with a genetic deviation that may be associated with fh. exclusion criteria: 1) age below 8 years.
comparison between two tacrolimus-based immunosuppressant regimens and induction with thymoglobulin in kidney transplants from deceased donors with expanded criteria

Conditions: Kidney Transplantation; Cytomegalovirus

Summary: the disparity between supply and demand for organs has stimulated the development of strategies to increase the availability of kidney grafts. such strategy involves the use of kidneys with expanded donor criteria (edc). this is a study initiated by the investigator, open, prospective, randomized, single center designed to compare the safety and efficacy of two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor criteria expanded.


Eligibility criteria:
inclusion criteria: * adults (\> 18 years) candidates to renal transplant with expanded criteria deceased donors; * low risk of acute rejection, defined as first kidney transplant recipients and panel reactive antibody (pra) \<50%. * signature of the informed consent form (icf) exclusion criteria: * patients receiving immunosuppressive therapy before transplantation; * patients who have received an investigational drug within last 30 days; * patients with a known contraindication to the administration of an anti-thymocyte globulin; * patients with a positive test for human immunodeficiency virus (hiv); * patients who had cancer (except non-melanoma skin cancer) within last two years; * pregnant women, breastfeeding women, and women of childbearing potential unwilling to use condoms or oral contraceptives will be excluded; * patients with any panel reactive antibody (pra) equal to or higher than 50%, class i or class ii, will also be excluded; * patients with positive test for parasites (protozoa and helminths).

Keywords: tacrolimus everolimus cytomegalovirus thymoglobulin deceased donors expanded criteria
transjugular intrahepatic portosystemic shunt (tips) for prevention of variceal rebleeding in cirrhotic patients with portal vein thrombosis

Conditions: Decompensated Cirrhosis; Portal Vein Thrombosis; Bleeding Varices

Summary: portal vein thrombosis (pvt) refers to an obstruction in the trunk of the portal vein. it can extend downstream to the portal branches, or upstream to the splenic and/or the mesenteric veins. the prevalence of pvt is 10-25% and incidence is about 16% in cirrhotic patients. recent studies demonstrate that the presence of pvt is not only an independent predictor of failure to control active variceal bleeding and prevent variceal rebleeding, but also significantly associated with increased mortality in patients with liver cirrhosis. however, in recent american association of the study of liver disease (aasld) practice guidelines and baveno v consensus, no treatment strategies in cirrhotic patients with pvt was clearly recommended due to the absence of randomized controlled trials.

usually, cirrhotic patients with pvt are submitted to variceal rebleeding prophylaxis with endoscopic band ligation combined with non-selective beta-blockers and, when necessary, the anticoagulation is started after the varices eradication. tips is just regarded as the second-line therapy for the secondary prophylaxis of variceal bleeding in cirrhotic patients. however, this indication might be changed in the setting of pvt. indeed, the risk to benefit ratio of tips in cirrhotic patients with pvt for the prevention of recurrent variceal bleeding has never been evaluated. the aim of this study is to compare the efficacy and safety of tips and endoscopic band ligation + propranolol in decompensated cirrhosis patients with pvt and a history of variceal bleeding in the past 6 weeks.

Eligibility criteria:
inclusion criteria: * written informed consent * liver cirrhosis * portal vein thrombosis (degree of vessel obstruction \> 50%) * history of variceal hemorrhage in the past 6 weeks (recent variceal bleeding has been controlled for at least 120 hours) exclusion criteria: * uncontrolled active variceal bleeding * fibrotic cord of the portal vein * prior history of tips placement or shunt surgery or endoscopic ban ligation +nsbb * concomitant renal insufficiency * severe cardiopulmonary diseases * uncontrolled systemic infection or sepsis * malignancy or other serious medical illness which may reduce the life expectancy * contraindications for propranolol, such as asthma, insulin-dependent diabetes (with episodes of hypoglycemia), and peripheral vascular disease * contraindications for heparin or warfarin * contraindications for tips
a study to evaluate the pk/pd and safety of ta-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the pk/pd and safety of ta-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.

this is an open-label, randomized, 2-way crossover study to evaluate the pk/pd and safety of ta-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients with type 2 diabetes mellitus who have normal renal function. the patients will receive both ta-7284-low and ta-7284-high orally alone in either period 1 or 2.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment * body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening * hba1c of ≥6.5% and ≤10.5% at screening exclusion criteria: * type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus * past or current history of severe diabetic complications * patients requiring insulin therapy * history of hereditary glucose-galactose malabsorption or primary renal glucosuria

Keywords: ta-7284 jnj-28431754 canagliflozin renal impairment sodium glucose co-transporter2 (sglt2) inhibitor
evaluating the safety of etanercept 50 mg twice weekly in subjects with psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (pasi) in subjects with psoriasis. this study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (pro); and characterize the pharmacokinetics (pk) profile of etanercept 50 mg twice weekly.


Eligibility criteria:
inclusion criteria: - active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - a minimum pasi score of 10 obtained during the screening period exclusion criteria: - active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis

Keywords: psoriasis, adults skin, phase 3 clinical trial, amgen etanercept, enbrel® moderate, severe
annex™ adjacent level system for treatment of adjacent level disease

Conditions: Degenerative Disc Disease; Adjacent Level Disease

Summary: the purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of the annex™ adjacent level system for the treatment of adjacent level disease of the lumbar spine. the annex™ adjacent level system is a spinal fixation system intended to be used with commercially available pedicle screw fixation systems in order to extend existing pedicle screw constructs. subjects will be evaluated over a 2 year period and compared to historical control.


Eligibility criteria:
inclusion criteria: * men or women 18-85 years of age * single level adjacent level segment disease (ald) in the lumbar spine (l1-s1). exclusion criteria: * trauma, tumor, pseudoarthrosis, revision, or same-level recurrent stenosis * cervical fusion candidates * extraspinal cause of back pain * local or systemic infection * pregnant / able to become pregnant and not following a reliable contraceptive method * severe osteoporosis or osteopenia * morbid obesity defined as bmi \> 40 * anatomy or other factors that prohibit safe surgical access to the surgical site * allergy or sensitivity to any component of the treatment procedure * inadequate tissue coverage over the operative site * inadequate bone stock or bone quality * fever or leukocytosis * uncorrectable coagulopathy or hemorrhagic diathesis * cardiopulmonary conditions that present prohibitive anesthesia risk * neuromuscular disease or disorder * mental illness * has an active workman's compensation claim
fiber and water improve bowel habit in humans

Conditions: Dietary Habits; Bowel Dysfunction

Summary: twenty healthy volunteers had their baseline parameters (symptoms, bowel habit, quality of life, fecal characteristics and microbiota) measured during a week of monitoring followed by randomization to a 14 days course of increased fiber in diet or increased fiber and water intake, with repetition of parameters measuring at the end.

demographic and clinical data were collected and recorded in the first interview after signing the informed consent. the protocol was composed of two phases. the baseline phase lasted 7 days, when participants reported their usual diet on a food dairy in the first 3 days, between sunday and tuesday. calculation of nutrient intake was performed using ads nutri software (ufpel, pelotas, brazil). participants approved for the next phase were then randomized to fiber and fiber+water groups, which lasted 14 days. during this period participants were asked to report their intestinal habits including bowel movements, graduation of straining and subjective stool consistency. participants were instructed to rank straining using a likert scale from 1 (minimum) to 5 (maximum), and the bristol scale for stool consistency. in the last day of treatment phase (saturday) participants collected feces and urine of 24 hours, and responded a symptoms questionnaire. food and liquid intake were recorded on a diary during the last 3 days of treatment for comparison with the baseline phase stage.

Eligibility criteria:
inclusion criteria: * non-obese * absence of abdominal complaints exclusion criteria: * use of medications that interfere with the gastrointestinal tract function * past of abdominal surgery * any acute or chronic disease
use of indocyanine green in robotic prostate surgeries

Conditions: Prostate Cancer Adenocarcinoma; Erectile Dysfunction Following Radical Prostatectomy

Summary: imaging of the vascular nerve bundle using indocyanine green

comparison of erectile function and surgical margin positivity after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery performed by imaging the vascular nerve bundle using indocyanine green with the results after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery without indocyanine green

Eligibility criteria:
inclusion criteria: * patients with low-intermediate risk prostate cancer exclusion criteria: * patients high risk prostate cancer

Keywords: erectile dysfunction and indocyanine green radical prostatectomy and indocyanine green
safety, tolerability and pharmacokinetics of ald1910 in healthy men and woman

Conditions: Migraine

Summary: the purpose of this study is to determine the safety, tolerability and pharmacokinetics of ald1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.

this is a first-in-humam, randomized, double-blind, placebo-controlled study in a healthy population. up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ald1910. approximately 96 healthy male and female participants are planned for the study, 64 for part a and 32 for part b.

Eligibility criteria:
inclusion criteria: 1. healthy male or female 2. all female subjects must have a negative pregnancy test result and subjects to use of adequate contraception for the duration of the study. 3. body mass index (bmi) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive. exclusion criteria: 1. use of prescription meds, nutritional supplements, otc medications. 2. new or unusually strenuous exercise for the duration of the trial. 3. current or previous drug or alcohol abuse. 4. current, or previous smoker within 12 weeks prior to screening. causal or social smokers are allowed. 5. previous treatment or clinical trial with a monoclonal antibody 6 months prior to screening. 6. current participation in any clinical research study. 7. ecg qtcf greater than or equal to 450 msec. 8. greater than 6.4% glycosylated hemoglobin (hgba1c) at screening 9. fasting blood glucose greater than or equal to 126 mg/dl (7 mmol/l) at screening
assessment of subjects' efficacy and experiences using adapalene bpo gel in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this study is to assess subjects' experiences using adapalene bpo gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.


Eligibility criteria:
inclusion criteria: * male or female subjects, aged 16 to 25 years inclusive; * subjects with mild or moderate facial acne (investigator's global assessment (iga) = 2 or 3; * a minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose); * subjects who agree to be photographed at each visit; * subjects who agree to be video recorded by study designated staff members. they should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study exclusion criteria: * subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment; * subjects with a wash-out period for topical acne treatment on the face less than 30 days * subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months; * subjects who are currently being treated with antibiotics; * subjects who foresee intensive ultraviolet (uv) exposure during the study (mountain sports, uv radiation, sunbathing, tanning beds, etc.); * subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials
oral corticosteroids for post-infectious cough in adults

Conditions: Post-infectious Cough

Summary: the purpose of this study is to assess whether a 5-day treatment with orally administered prednisone provides patient-relevant benefits by improving the cough-related qol of patients with post-infectious cough triggered by an upper respiratory tract infection (urti) and seeking care in adult primary care practices. the study aims to describe an efficacy and safety profile for a 5-day prednisone treatment compared to a 5-day course of placebo.


Eligibility criteria:
inclusion criteria: * patients seeing a gp for a dry or productive post-infectious cough (3 to 8 weeks) after upper respiratory tract infection (urti) * patients able and willing to give informed consent by themselves and to fill in the lcq on day 0 with the gp and to answer phone calls from the research staff/study nurse at day 7, 14, and 28, and at 3 months for outcome assessment exclusion criteria: * patients with known or suspected diagnoses associated with cough, such as: pneumonia or suggestive symptoms and signs (abnormal vital signs, i.e. heart rate \>100/min, respiratory rate \>25/min, fever), allergic rhinitis, sinusitis, bronchial asthma, chronic pulmonary disease (copd), or gastroesophageal reflux disease, * patients with other chronic disease such as bronchiectasis, cystic fibrosis, cancer, tuberculosis, heart failure. * use of inhaled or oral corticosteroids within the last four weeks * immunodeficiency/immunocompromised state (e.g. cancer chemotherapy, hiv infection, administration of immune-suppressive agents) * pregnancy/ breastfeeding * regular treatment known to be associated with cough (e.g. angiotensin converting enzyme inhibitors) * patients with pharmacotherapy for glaucoma or osteoporosis * experienced fractures due to osteoporosis * patients with uncontrolled diabetes (as deemed by gps who appraise whether the potential side effects of short-time corticosteroids on glucose levels exceed the hypothesised benefit on cough)

Keywords: upper respiratory tract infection oral corticosteroid treatment cough-related quality of life (qol)
an observational study to learn about the interferon-beta exposure of pregnant women during the second and third trimester in finland and sweden

Conditions: Multiple Sclerosis (MS)

Summary: observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (ifnb) before or during pregnancy. after the emergence of these data, the european medicines agency approved a label change for ifnb in september 2019, stating that use of ifnb during pregnancy may be considered, if clinically needed. however, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed. inform is a secondary use of data drug utilisation study (dus) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to ifnb in finland and sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure. the number of pregnancies will be initially reported three years after the revised label implementation (september 2019) and will include data on pregnancies from 1996 in finland and from 2005 in sweden up through 31 december 2022. if the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this dus will be finalised with the drug utilisation data accrued up through 31 december 2022. if the number of pregnancies until 31 december 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 december 2024.


Eligibility criteria:
inclusion criteria: * women with a diagnosis of ms disease, regardless of ms clinical type, recorded at least once during the full study period. * women with at least one recorded pregnancy after the ms diagnosis (including pregnancies ending in live birth, stillbirth, spontaneous abortion, ectopic pregnancy, or elective termination) exclusion criteria: - none.
efficacy evaluation of a mixed compound of antioxidants in terms of endothelium damage/function in pediatric subjects with obesity.

Conditions: Childhood Obesity

Summary: the aim of our study was to test the effects on endothelium of a combination of curcumin, resveratrol, plus zinc, magnesium, selenium and vitamin d in a cohort of pediatric subjects with obesity.

the aim of our study was to test the effects on endothelium of a combination of curcumin, resveratrol, plus zinc, magnesium, selenium and vitamin d in a cohort of pediatric subjects with obesity. endothelial function was assessed using two methodologies: a "post occlusive release hyperemic test" (porh) and a "heat provocation test" (hpt). treatment tablet composition (auxilie® immuplus, envicon medical, verona, italy): vitamin d3: 25,00 mcg, folic acid: 90,00 mcg, selenium: 55,00 mcg magnesium: 300,00 mg, zinc: 7,00 mg, curcum (meriva®): 100,00 mg polygonum dry extract: 20,41 mg (of which resveratrol: 20,00 mg), soy dry extract: 37,50 mg. placebo tablet composition: saccharose, fructose, aroma, anti-agglomerate agents: fatty acids magnesium salts, silicium dioxide, colorant: riboflavin 5-sodium phosphate; sweetener: stevia glycoside, sucralose, neosperidin dc. both tablets (treatment and placebo) were similar in form, color and flavor.

Eligibility criteria:
inclusion criteria: * diagnosis of obesity as defined by a bmi higher than the 95 percentile for age based on the cdc standard * age 6-17 years exclusion criteria: * children with genetic syndromes or cardiovascular diseases were excluded from the study